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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002335
Receipt No. R000002857
Scientific Title The effect of sacral surface electrical stimulation for assisted reproductive technology
Date of disclosure of the study information 2009/08/14
Last modified on 2010/02/15

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Basic information
Public title The effect of sacral surface electrical stimulation for assisted reproductive technology
Acronym The effect of sacral surface electrical stimulation for assisted reproductive technology
Scientific Title The effect of sacral surface electrical stimulation for assisted reproductive technology
Scientific Title:Acronym The effect of sacral surface electrical stimulation for assisted reproductive technology
Region
Japan

Condition
Condition Infertile women required for assisted reproductive technology
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Improvement of pregnancy rates for assisted reproductive technology
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Morphological changes of the uterus at embryo transfer
Key secondary outcomes Pregnancy rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Sacral surface electrical stimulation
Interventions/Control_2 control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Infertile women
Key exclusion criteria uterine myoma, adenomyosis, hydrosalpinx,
history of ectopic pregnancy
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Murakami
Organization Shiga university of medical science
Division name Obsatetrics and gynecology
Zip code
Address Tsukinowa-cho, otsu, shiga
TEL 077-548-2267
Email

Public contact
Name of contact person
1st name
Middle name
Last name Wakasa Yamaguchi
Organization Shiga university of medical science
Division name Obsatetrics and gynecology
Zip code
Address Tsukinowa-cho, otsu, shiga
TEL 077-548-2267
Homepage URL
Email

Sponsor
Institute Shiga university of medical science
Institute
Department

Funding Source
Organization Shiga university of medical science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2009 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 14 Day
Last modified on
2010 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002857

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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